NCT06443866 I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer
| NCT ID | NCT06443866 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Miami Cancer Research Center, Inc. |
| Condition | Thyroid Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2022-02-01 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study is to demonstrate the clinical utility of I-124 PET/CT imaging and dosimetry in patients with thyroid cancer including 1) Evaluation of extent (volume and pattern) of remnant tissue in post total thyroidectomy setting and distinction of nodal metastases vs remnant tissue for determination of indication for RAI ablation, 2) Evaluation of response to RAI remnant ablation, 3) Evaluation for suspected occult recurrent/metastatic disease, 4) Evaluation of extent of disease in patients with known metastatic disease and 5) Evaluation of RAI avidity of recurrent/metastatic thyroid cancer and response to treatment with thyroid kinase inhibitors (TKI). Patients who underwent total thyroidectomy for thyroid cancers are studied. Patients who are newly diagnosed, as well as those who have known or suspected to have recurrent or metastatic disease are eligible. Patients receiving TKI treatment are eligible for evaluation prior to and after the treatment. The patients who are considered for TKI/MAPK treatments undergo pre and post treatment with clinically determined oncoprotein/TKR therapeutic agent(s), including multi-TKI, selective BRAF, MEK, PI3K or ERK inhibitors or combination treatments.
Eligibility Criteria
Inclusion Criteria * Post-total thyroidectomy patients with diagnosis of thyroid cancer, any histology, subtype, any ATA risk category, for evaluation for residual disease, cervical or remote metastatic disease * Patients with known or suspected recurrent/metastatic thyroid cancer, identified by ultrasound (US), CT/MR/FDG-PET\|CT or elevated thyroglobulin (Tg). * Pretreatment and post-treatment evaluation of patients with thyroid cancer deemed RAI-indifferent/refractory who are considered for TKI * Age ≥ 18 * Ability and willingness to give a written consent * Life expectancy \> 3 months * ECOG performance status ≤ 2 Exclusion Criteria * Cancers metastatic to thyroid * Age \< 18 * Inability or unwillingness to give a written consent * Life expectancy \< 3 months * ECOG performance status ≥ 3 * Pregnant and nursing women.
Contact & Investigator
Seza Gulec, MD
PRINCIPAL INVESTIGATOR
CEO, MCRC
Frequently Asked Questions
Who can join the NCT06443866 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06443866 currently recruiting?
Yes, NCT06443866 is actively recruiting participants. Contact the research team at sezagulec@gmail.com for enrollment information.
Where is the NCT06443866 trial being conducted?
This trial is being conducted at North Miami, United States.
Who is sponsoring the NCT06443866 clinical trial?
NCT06443866 is sponsored by Miami Cancer Research Center, Inc.. The principal investigator is Seza Gulec, MD at CEO, MCRC. The trial plans to enroll 50 participants.
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